WASHINGTON – CDRH Director Jeffrey Shuren encouraged the increased use of real-world evidence (RWE) and put an emphasis on the FDA's total product life cycle (TPLC) reorganization during his presentation last week at the Food and Drug Law Institute's annual conference. At the same time, he provided an overview of CDRH's current activities, including implementation of 21st Century Cures, as well as the center's vision for the future. Read More
Suzanne Grant says it all happened quite by accident, running into Australian scientists Stephen Prawer and Michel Pigeon who had traveled all the way to Ottawa to sell entrepreneurs on their idea: to leverage the principles underpinning the Cochlear device for people with hearing loss to create a device that restores sight in people rendered blind by eye-related diseases. Read More